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Senior Director, Head Of Clinical Operations
2 weeks ago
This role is based either in the East Coast of the USA (remote) or in our Paddington office in the UK (office based).Job DescriptionSenior Director, Head of Clinical OperationsOur Destination"Computing the future of medicine." We are integrating the latest advances in data science and artificial intelligence to develop life-transforming RNA interference (RNAi) medicines.We combine cutting-edge computation and AI with RNAi to make better medicines faster.
Our unique approach enables us to differentiate, de-risk, and rapidly deploy our enabling platforms (HepNet and GalOmic) to create novel GalNAc-siRNA therapies, improving upon traditional approaches to drug discovery.Our rapid and reproducible process has produced a broad therapeutic pipeline of GalOmic RNAi therapies targeting novel genes that have demonstrated disease-modifying potential in preclinical disease models.
We are advancing our pipeline towards the clinic, with our most advanced asset (ETX-312, for the treatment of MASH) currently undergoing IND-enabling studies, the final stage of preclinical development.It is an incredibly exciting time for ETX, as we get closer to delivering on our mission of delivering life-transforming medicines to patients and ultimately realizing the full potential of our AI-enhanced approach to drug discovery.Your AdventureThis position offers an amazing opportunity to create and lead the Clinical Operations function and bring a portfolio of ETX programmes across a range of therapeutic areas into the clinic.Reporting to the Vice President, Head of Early-stage Development, the Senior Director, Head of Clinical Operations will be a key member of the ETX team, providing input to clinical trial design and regulatory dossiers and responsible for clinical operational strategy and execution.What you will doOversee the strategic and operational management of translational through proof-of-concept clinical development programmes in multiple therapeutic areas; responsible for timelines, quality and budget in alignment with the corporate pipeline/portfolio strategy and objectives.Establish and manage the clinical operations function that strategically leverages external clinical vendors.Work closely with a cross-functional team fostering a collaborative and high-performance culture; responsible for mentoring, coaching and development of direct reports.Serve as the main point of clinical programme contact for internal stakeholders (Senior and Executive leadership teams, CMC, business development, finance) and external stakeholders (CROs, consultants, advisors, ethics, regulatory authorities), ensuring clear and timely communication.Define and track key milestones, deliverables, and programme performance metrics, providing regular progress updates to the Senior and Executive leadership teams.Identify, assess, and manage risks across programmes, developing mitigation strategies to ensure successful outcomes.Manage programme and clinical portfolio budgets, resource allocation, and financial forecasting, ensuring cost-effective delivery and alignment with corporate financial goals.Manage clinical service providers (including CROs, central labs, specialist labs, reading centres and other vendors) from qualification, selection & contract negotiation to ongoing relationship management.Review plans and provision of clinical operations expertise during protocol design, feasibility, study start-up and conduct phases of studies.Contribute to regulatory documents, data analysis, study reports and publications.Skills & qualificationsEssential:Degree in a relevant scientific discipline (e.g.
life sciences, pharmacy, nursing).At least 10 years of biopharmaceutical clinical project management and/or function leadership.Experience of leading early phase clinical research and development, including first-in-human studies.Experience with clinical development of biologics or advanced therapies, e.g.
siRNA, oligonucleotides etc.Expert project management skills, cross-functional engagement and organizational skills.Budget management expertise and strong financial & commercial acumen.Strong analytical skills with a data-driven approach to planning, executing, and problem-solving with an ability to prioritize; managing the details whilst keeping programme goals in mind.Excellent verbal and written communication skills, with experience writing regulatory and clinical documents and presenting to international scientific and medical experts.Successful history of collaborating and building relationships with key opinion leaders, study investigators and their teams.Strong understanding of regulatory requirements and ICH/GCP guidelines.Nice to have:Experience working in a biotech environment.Experience leading global clinical programmes and presenting to regulatory authorities.Experience in leading rare disease clinical programmes and working with patient advocacy groups or research networks.Experience in metabolic programmes, e.g.
MASH.Project management certification (PMP, PRINCE2).Our culture & valuesOur success starts & ends with our team – the passionate, curious and collaborative individuals who work here.
All are committed to pushing technology to the limit to make a difference to patients, to R&D and to each other – we call this our PACT.We're not looking for people who are exactly like us.
We're looking for people who care about and value the same guiding principles while bringing different ideas, perspectives & opinions.Our benefitsWe invest in your success:Competitive salary.Discretionary performance-related bonus.PACT awards (monthly recognition scheme).If USA based:We care about you:Private medical cover with United Healthcare.Dental plan with Delta Dental.Vision plan with VSP Vision Care.We help you protect your future:2% contribution to 401(k) up to a maximum of $6,900/annum with 3% salary enhancement to help you increase your retirement plan contributions.Life insurance (2 x annual salary up to maximum $400,000).We unlock your potential:Personal development time.Departmental learning and development budget (including attending external training, conferences, etc.
).We make it fun:Bi-annual social event.22 days PTO + 11 US public holidays.If UK based:We care about you:Private medical cover with Bupa.Medicash Health Cash Plan.Employee Assistance Programme.Reward Gateway (deals & discounts and wellbeing centre).Annual season ticket loan.We help you protect your future:10% employer pension contribution (you can also make your own contributions via salary sacrifice).Life insurance (4 x annual salary).We unlock your potential:Personal development time.Departmental learning and development budget (including attending external training, conferences, etc.
).We make it fun:Social and well-being events throughout the year such as a newly created ETX Summer dodgeball team, bouldering, pizza making sessions and we even have a basketball court on our roof terrace25 days of annual leave + public holidays.EDI StatementOur ambition is to have a positive impact on society at a global level by discovering and developing novel therapeutic targets in areas of high unmet need.We believe that providing equal opportunities, valuing diversity, and promoting a culture of openness and inclusivity are vital in the journey to realize our ambition.
We therefore aim to create an environment where people are free to be themselves regardless of their identity or background.
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